DEA Rules Fenfluramine No Longer Controlled Substance, Positive FDA ADComm Meeting of Brexpiprazole, Antiamyloid Drugs Accelerate Brain Atrophy

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Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

Originally marked as a Schedule IV controlled substance, the US Drug Enforcement Administration (DEA) has published its final ruling on fenfluramine (UCB Pharma; Fintepla) stating that the oral medication is no longer subject to the Controlled Substances Act (CSA). Following receipt of this DEA rule, UCB has filed a labeling supplement with the FDA to remove Schedule IV designation from the medication. Fenfluramine, an antiseizure medication, originally received FDA-approval as a therapy for Dravet syndrome in patients aged 2 years and older in 2020, and later for the treatment of Lennox-Gastuat syndrome in March 2022. With the new ruling, most prescribers will be able to write a prescription for a full year’s supply versus the current limitation of 6 months. Prescribers will also now have the option to send a prescription to pharmacies electronically.

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has voted that the current data on brexpiprazole (Rexulti; Otsuka/Lundbeck), an agent under review for Alzheimer disease (AD) agitation, have shown enough evidence of benefit to outweigh its potential risks. The agent currently has a PDUFA date of May 10, 2023, and, if approved, would be the first agent specifically to treat AD agitation. The committee was asked to vote on whether the provided data was sufficient to allow the identification of a population in whom the benefits of treating agitation associated with Alzheimer dementia with brexpiprazole outweighed its risks. At the end of the hearing, the committee voted 9–1 (9 yes; 1 no; 0 abstain) in favor of the agent.

Recently published findings from a meta-analysis of trials that assessed anti-amyloid therapies at their highest dose revealed that drug-induced acceleration of volume changes in hippocampus, ventricle, and whole brain atrophy. In addition, investigators identified an arresting correlation between the frequency of amyloid-related imaging abnormalities (ARIA) with the degree of ventricular enlargement. The meta-analysis included 31 trials of anti-amyloid drugs that demonstrated favorable change on at least 1 biomarker of pathological amyloid-ß and had detailed MRI data sufficient to access the volumetric changes in at least 1 brain region. At the conclusion of the analysis, investigators provided a number of recommendations, including that "data safety monitoring boards (DSMB) serving current clinical trials of anti-Aβ drugs should review volumetric data to determine if patient safety is at risk, particularly in patients that develop ARIA.

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